Long-term safety and tolerability of cenerimod in adults with systemic lupus erythematosus (OPUS OLE)
- Registration Number
- 2024-514354-67-00
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
The primary objective of the study is to assess the long-term safety and tolerability of cenerimod 4 mg on top of background therapy in subjects with systemic lupus erythematosus (SLE).
- Detailed Description
Participants who completed the 12-month double-blind treatment period (cenerimod 4 mg or placebo) in either of the parent studies, ID-064A301 or ID-064A302, are eligible to participate in this extension study.
All participants in this study will receive cenerimod 4 mg for at least 12 months (1 year) and up to a maximum of 36 months (3 years). All participants may additionally receive standard of care treatment for systemic lupus erythematosus, i.e., at least 1 of the following: oral corticosteroids, antimalarial drugs, or immunosuppressant drugs.
When all participants have reached at least 12 months of study treatment or have prematurely discontinued study treatment before the end of Month 12, the end-of-treatment will be scheduled for all participants who are still on study treatment.
The safety follow-up period starts on the day after the last dose of study treatment and ends after 6 months with the final study visit. Thus, the maximum duration of participation is 3.5 years.
Data collected in this extension study will allow an assessment of whether the safety and tolerability profile of cenerimod established in the controlled parent studies remains the same after a longer period of treatment.
Recruitment & Eligibility
- Status
- Authorised, recruiting
- Sex
- Not specified
- Target Recruitment
- 172
Signed and dated informed consent form prior to any study-mandated procedure.
Male and female participants (aged 18-75 years) with a diagnosis of systemic lupus erythematosus who: • Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302). • Did not meet any study treatment stopping criteria during the parent study. • Completed the last scheduled visit of the parent study. Participants who did not complete the last scheduled visit for reasons beyond their control maybe eligible for this study upon approval by the sponsor.
For women of child-bearing potential: • Negative pregnancy test at Visit 1. • Agreement to undertake monthly urine pregnancy tests from Visit 2 up to 6 months after study treatment discontinuation. • Agreement to use a highly effective method of contraception from Visit 1 up to 6 months after study treatment discontinuation.
Poor compliance with study-mandated procedures during the parent study (ID-064A301 or ID-064A302),e.g., took less than 80% of the planned doses of double-blind study treatment; or did not attend a majority of the site visits, unless there was a medically justified reason as judged by the investigator.
Systemic lupus erythematosus driven renal disease, central nervous system lupus, or active severe or unstable neuropsychiatric systemic lupus erythematosus where, in the judgment of the investigator, protocol-specific systemic lupus erythematosus background therapy is insufficient, and the use of a more aggressive therapeutic approach or other treatments not permitted in the protocol is indicated.
Women of child-bearing potential planning to become pregnant up to the final study visit.
Judged not eligible to participate by the investigator, for any other reason.
Confirmed active or latent tuberculosis (applicable only if requested by local regulations).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description cenerimod cenerimod Participants receiving cenerimod
- Primary Outcome Measures
Name Time Method Occurrence of treatment-emergent adverse events up to the final study visit. Occurrence of treatment-emergent adverse events up to the final study visit.
Occurrence of serious adverse events up to the final study visit. Occurrence of serious adverse events up to the final study visit.
Occurrence of adverse events of special interest (i.e., anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities) up to the final study visit. Occurrence of adverse events of special interest (i.e., anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities) up to the final study visit.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
University General Hospital Attikon
🇬🇷Athens, Greece
Athens Naval Hospital
🇬🇷Athens, Greece
Euromedica Kyanous Stavros
🇬🇷Thessaloniki, Greece
General University Hospital Of Larissa
🇬🇷Larissa, Greece
Laiko General Hospital Of Athens
🇬🇷Athens, Greece
Hippokration Hospital
🇬🇷Thessaloniki, Greece
General University Hospital Of Patras
🇬🇷Patras, Greece
424 Military General Training Hospital
🇬🇷Thessaloniki, Greece
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
🇩🇪Frankfurt Am Main, Germany
Universitaetsklinikum Leipzig AöR
🇩🇪Leipzig, Germany
Scroll for more (36 remaining)University General Hospital Attikon🇬🇷Athens, GreeceDimitrios BoumpasSite contact00305831990boumpasd@uoc.gr